StrokeNCT07395544
Gait Training for Hemiplegic Stroke Patients With Stationary Trainer
A study testing NDT Gait Training System in people with Stroke, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
Trial summary
This study aims to evaluate the effectiveness of a novel mobile neurodevelopmental treatment (NDT) gait training device for patients recovering from stroke. Stroke is a major cause of disability worldwide, and many survivors experience difficulty with walking and require long-term rehabilitation. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- NDT Gait Training System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 20 years, first-ever stroke, with Brunnstrom stage III to IV of the affected lower limb motor recovery.
- Functional Ambulation Category (FAC) level IV.
- Ability to ambulate on level ground without assistive devices.
- Ability to understand instructions and cooperate with assessments.
Who cannot join
- Presence of severe spinal cord injury or peripheral neuropathy.
- Unstable gait requiring assistive devices, or participants at high risk of falling.
- Severe impairment in vision, hearing, or cognition, making them unable to comply with assessments.
- Lower limb fracture within the past 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Gait Training for Hemiplegic Stroke Patients: Employing a Stationary Neuro-developmental Trainer With Auditory Cues
This study aims to evaluate the effectiveness of a novel mobile neurodevelopmental treatment (NDT) gait training device for patients recovering from stroke. Stroke is a major cause of disability worldwide, and many survivors experience difficulty with walking and require long-term rehabilitation. NDT is a widely used rehabilitation approach that focuses on improving motor control through techniques such as facilitation, inhibition, and key point control. However, traditional NDT gait training can be physically demanding for therapists and often limits the training intensity and duration for patients.
To address these challenges, this study introduces an automated NDT gait training device that replicates therapist techniques using mechanical support and sensory feedback. The system uses bilateral dynamic assistance at the waist, auditory cues, and wearable inertial measurement units (IMUs) to help patients practice natural and symmetric walking patterns on the ground, instead of being restricted to treadmill training. The IMUs also provide objective gait data to assess improvement in gait symmetry, pelvic rotation, walking speed, and cadence.
The primary goal is to assess changes in these gait parameters before and after NDT-based intervention. The study plans to enroll 40 adult stroke survivors (aged 20 and older) over a 3-year period starting from May 1, 2024.
- Conditions
- Stroke
- Being tested
- NDT Gait Training System
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NDT Gait Training SystemDevice
The intervention includes a NDT gait training device that mimics therapist techniques through mechanical assistance, synchronized with auditory feedback and real-time gait analysis using IMU sensors.
| Study group | Role | What they receive |
|---|---|---|
| NDT gait training group | Experimental | NDT gait trainer which can automatically repeat NDT intervention, thereby alleviating therapists' workload and extending patients' training time. They analyzed therapists' intervention in manual NDT training and concluded that therapists cued subjects' anterior superior iliac spines (ASISs) when perceiving opposite heel strikes (HSs). Receives: Device: NDT Gait Training System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic rotation
The gait parameter will be collected using wearable inertial measurement units (IMUs) before and after the NDT gait training intervention and pelvic rotation will be measured through axial angular velocity
Measured: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).
Walking speed
Walking speed will be estimated from IMU during walking and reported in meters per second (m/s).
Measured: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).
Step length
Step length will be derived from IMU-based spatiotemporal gait data collected during overground walking and reported in meters (m).
Measured: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start2 May 2024
- Primary completion5 Dec 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In this study, inertial measurement units are used for gait phase detection and as feedback parameters for the system. Previous studies have validated the reliability and accuracy of IMU data compared to those collected in motion analysis laboratories.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cheng-Hsin General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Szu-Fu Chen, MD, PhD, Principal investigator, Cheng-Hsin General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395544
- Sponsor's protocol ID
- CHGH-(1069)112A-60
- Status last verified
- Feb 2026
- First submitted
- 17 Jul 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Training for Hemiplegic Stroke Patients: Employing a Stationary Neuro-developmental Trainer With Auditory Cues
- ClinicalTrials.gov ID
- NCT07395544
- Acronym / sponsor ID
- CHGH-(1069)112A-60
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cheng-Hsin General HospitalUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effectiveness of a novel mobile neurodevelopmental treatment (NDT) gait training device for patients recovering from stroke. Stroke is a major cause of disability worldwide, and many survivors experience difficulty with walking and require long-term rehabilitation. NDT is a widely used rehabilitation approach that focuses on improving motor control through techniques such as facilitation, inhibition, and key point control. However, traditional NDT gait training can be physically demanding for therapists and often limits the training intensity and duration for patients.
To address these challenges, this study introduces an automated NDT gait training device that replicates therapist techniques using mechanical support and sensory feedback. The system uses bilateral dynamic assistance at the waist, auditory cues, and wearable inertial measurement units (IMUs) to help patients practice natural and symmetric walking patterns on the ground, instead of being restricted to treadmill training. The IMUs also provide objective gait data to assess improvement in gait symmetry, pelvic rotation, walking speed, and cadence.
The primary goal is to assess changes in these gait parameters before and after NDT-based intervention. The study plans to enroll 40 adult stroke survivors (aged 20 and older) over a 3-year period starting from May 1, 2024.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this study, inertial measurement units are used for gait phase detection and as feedback parameters for the system. Previous studies have validated the reliability and accuracy of IMU data compared to those collected in motion analysis laboratories.
| Arm | Type | Receives |
|---|---|---|
| NDT gait training group | Experimental | Device: NDT Gait Training SystemNDT gait trainer which can automatically repeat NDT intervention, thereby alleviating therapists' workload and extending patients' training time. They analyzed therapists' intervention in manual NDT training and concluded that therapists cued subjects' anterior superior iliac spines (ASISs) when perceiving opposite heel strikes (HSs). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 20 years, first-ever stroke, with Brunnstrom stage III to IV of the affected lower limb motor recovery.
- Functional Ambulation Category (FAC) level IV.
- Ability to ambulate on level ground without assistive devices.
- Ability to understand instructions and cooperate with assessments.
Key exclusion criteria (4 listed)
- Presence of severe spinal cord injury or peripheral neuropathy.
- Unstable gait requiring assistive devices, or participants at high risk of falling.
- Severe impairment in vision, hearing, or cognition, making them unable to comply with assessments.
- Lower limb fracture within the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NDT Gait Training SystemThe intervention includes a NDT gait training device that mimics therapist techniques through mechanical assistance, synchronized with auditory feedback and real-time gait analysis using IMU sensors. | Device | NDT gait training group |
Primary outcome
Pelvic rotation
Time frame: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).
The gait parameter will be collected using wearable inertial measurement units (IMUs) before and after the NDT gait training intervention and pelvic rotation will be measured through axial angular velocity
Walking speed
Time frame: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).
Walking speed will be estimated from IMU during walking and reported in meters per second (m/s).
Step length
Time frame: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training intervention).
Step length will be derived from IMU-based spatiotemporal gait data collected during overground walking and reported in meters (m).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Szu-Fu Chen, MD, PhD principal investigator
Cheng-Hsin General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NDT Gait Training System in people with Stroke, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic rotation (time frame: Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.